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Biotechnology is an area of growing domestic and international importance to the manufacturing sector, and this summer the federal government announced several important biotechnology initiatives of which stakeholders should be aware. This article from the Winter, 2015, issue of Environmental Quality Management explains each initiative, and outlines why stakeholders are encouraged to engage in each one.

A November 30, 2015 story in Bloomberg BNA Daily Environment Report on the federal approach to regulating bioengineered products and comments submitted by nearly a thousand organizations and individuals on the Coordinated Framework for the Regulation of Biotechnology, featured commentary from B&C: Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural...

B&C Managing Partner and Product Stewardship Society Board Member Lynn L. Bergeson’s presentation "Legal and Stewardship Issues Associated with EPDs and HPDs" was featured in the society’s Full Circle Blog:  “Regardless of what the law requires, disclosure is fast becoming a commercial imperative, especially for companies wanting to establish themselves as ‘green,’ said Lynn Bergeson, managing partner, Bergeson & Campbell, PC, during a session at...

The November 25, 2015, Bloomberg BNA Daily Environment Report quoted Bergeson & Campbell, P.C., in the article “Diverse Parties Say Federal Biotech Rules Confusing.” Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural problems that may thwart the White House's intentions. The regulatory infrastructure is ill-suited to address synthetic biology—a new form of...

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, the U.S. Environmental Protection Agency (EPA) filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC's (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case commenced in...

On November 24, 2015, Inside EPA published the article “TSCA Bill Faces Implementation Hurdles Despite Potential For Senate Vote.”  Jim V. Aidala was quoted discussing a possible implementation timeline if the TSCA Reform bill was passed. Former EPA toxics official Jim Aidala, now with the law firm Bergeson & Campbell, at the ELI event identified some of the time frames on rulemakings, new definitions, and administrative fees as potential "early implementation hurdles"...

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies' application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it "thoroughly...

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According to an item in the U.S. Environmental Protection Agency's (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive information and comments on the use of the term 'natural' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering." FDA states that this action is a result of three...